A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease

NCT01482845 | Completed Phase 1

• 1 other identifier: M12-970
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

This study will investigate safety, tolerability and pharmacokinetics of ABT-126 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessments

  vital signs, electrocardiogram (ECG), neurological examination, laboratory tests, number of subjects with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS)

  From Day 1 through Day 17

Secondary Outcomes (1)

• Pharmacokinetic evaluation profile

  Blood collection prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 72, 120, and 168 hours after dosing on Day 10

Study Arms (2)

Group 1

EXPERIMENTAL

Drug: ABT-126; Drug: Placebo

Group 2

EXPERIMENTAL

Drug: ABT-126; Drug: Placebo

Interventions

ABT-126 DRUG

Dose 1 is given to 8 subjects in Group 1. Dose 2 is given to 8 subjects in Group 2. All doses will be administered once daily in the morning for 10 days.

Group 1; Group 2

Placebo DRUG

Placebo is given to 2 subjects each in Group 1 and Group 2. All doses will be administered once daily in the morning for 10 days.

Group 1; Group 2

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female and age between 55 and 90 years, inclusive.
• The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease (AD).
• The subject has a Mini-Mental State Examination (MMSE) total score of 16 to 26, inclusive, at Screening Visit.
• The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit.
• The subject must be on a stable dose of donepezil or rivastigmine for at least 1 month prior to study drug administration.
• The subject has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization and after the subject met NINCDS/ADRDA diagnostic criteria for probable AD. The scan must not show evidence for an alternative etiology for dementia.

You may not qualify if:

• Receipt of an investigational product within 6 weeks prior to study drug administration.
• History of significant sensitivity or allergy to any drug.
• History of any significant neurological disease other than AD.
• Significant current suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening or any history of suicide attempts.

Sponsors & Collaborators

• Abbott: lead

Study Sites (3)

Site Reference ID/Investigator# 62908

Glendale, California, 91206, United States

Location

Site Reference ID/Investigator# 62904

Hallandale, Florida, 33009, United States

Location

Site Reference ID/Investigator# 62903

Orlando, Florida, 32806, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

ABT-126

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hana Florian, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: December 1, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 2, 2012

Record last verified: 2012-03

Locations

US (3)